Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT00272480
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To determine whether the use of two antiviral agents in combination will be better than placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I

Condition or Disease	Intervention/Treatment	Phase
HTLV-I-associated Myelopathy	Drug: Zidovudine/lamivudine; Drug: Placebos	Phase 2/Phase 3

Detailed Description

Randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine in HAM/TSP 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by 6 months open-label therapy with active drug Primary endpoint: clinical Secondary endpoints: virological and immunological

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
• Actual Study Start Date: Nov 8, 1999
• Actual Primary Completion Date: Jul 30, 2002
• Actual Study Completion Date: Jul 30, 2002

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo in HAM/TSP 24	Drug: Placebos
Active Comparator: Zidvoudine plus lamivudine Zidvoudine plus lamivudine in HAM/TSP 24	Drug: Zidovudine/lamivudine

Outcome Measures

Primary Outcome Measures

1. Timed walk [6 months]

   Time taken to walk 13m

2. Osame's Motor Disability Score [6 months]

   0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)

3. Pain score [6 months]

   11 point Visual Analogue Scale 0 = no pain, 10 = worse pain

4. Urinary frequency [6 months]

   Number of times passing urine during the daytime

5. HTLV-1 proviral load [6 months]

   The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells

Secondary Outcome Measures

1. CD25% [6 months]

   Expression of CD25 on T-cells

2. HLA-DR% [6 months]

   Expression of HLA-DR on T-cells

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HTLV-I-associated myelopathy

Exclusion Criteria:

• prior exposure to zidovudine or lamivudine on disease modifying therapy

• under age 16

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College	London		United Kingdom	W2 1PG

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Graham P Taylor, FRCP, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

• Taylor GP et al The Bridge Study - A double-blind, placebo controlled trial of zidovudine plus lamivudine for the treatment of patients with HTLV-I-associated myelopathy AIDS Research and Human Retroviruses 2003;19 (suppl 1) #O23

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT00272480
• Other Study ID Numbers: BRIDGE1.0
• First Posted: Jan 6, 2006
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: HAM/TSP; HTLV-I-associated myelopathy; zidovudine; lamivudine; antiretroviral therapy
• Additional relevant MeSH terms: Paraparesis, Tropical Spastic; Spinal Cord Diseases; Bone Marrow Diseases; Lamivudine; Zidovudine

Study Results

No Results Posted as of Aug 25, 2021